Inad 681014Recalls & reported problems
Inrad · PreciseCore Biopsy 14 ga x 10 cm 20 mm notch · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00817295020817), received between Dec 3, 2021 and Dec 3, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Product Quality Problem” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Product Quality Problem2
Patient problems
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 3, 2021Product Quality Problem; Product Quality Problem
THREE SMALL METAL PIECES WERE LEFT IN THE BREAST AFTER USING AN INRAD BIOPSY DEVICE, A TUMARK Q CLIP AND A 25G X 1 1/2 BD ECLIPSE NEEDLE. INRAD 14GX10CM-LOT #62101001- REF#681014- EXPIRATION DATE: 01/06/24 HOLOGIC PROFESSIONAL Q SHAPE CLIP- LOT#51612- REF#351222- EXPIRATION DATE: 04/18/26 BD ECLIPSE NEEDLE 25G X 1 1/2 - LOT#1002329- REF#305767 - EXPIRATION DATE: 12/31/25.
Patient problems: Foreign Body In Patient
MAUDE report 12923424 ↗InjuryDec 3, 2021Product Quality Problem; Product Quality Problem
TWO VERY SMALL METALLIC FRAGMENTS IN THE AREA OF THE NEEDLE TRACT ON THE POST-BIOPSY MAMMOGRAMS.
Patient problems: Foreign Body In Patient
MAUDE report 12923391 ↗
Other Instrument, Biopsy devices
- MAX-CORE MC1616Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall4,258 reports
- ENCOR® ECP017GSenorx, Inc. · INSTRUMENT, BIOPSY1 recall4,186 reports
- MAX-CORE MC1820Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall2,404 reports
- MAX-CORE MC1816Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall1 death848 reports
- MAX-CORE MC1410Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall399 reports
- MAX-CORE MC1610Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall394 reports
- ENCOR® ECP0110GVSenorx, Inc. · INSTRUMENT, BIOPSY392 reports
- ENCOR® ECP0110GSenorx, Inc. · INSTRUMENT, BIOPSY390 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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